Feature, Report

An IOL to change the cataract surgery paradigm?

Alcon’s newest EDOF intraocular lens has only been available to a handful of Australian ophthalmologists, but it’s already receiving major plaudits. Could it really change the game for cataract patients and spell the end of monofocals as we know them? MYLES HUME explains. 

There is a buzz building in Australian ophthalmological circles about a new extended depth of focus intraocular lens (EFOF IOL) that some are anticipating could become the default lens for cataract surgeons.

The Alcon AcrySof IQ Vivity Extended Vision IOL has only been used by a limited number of Australian ophthalmologists for a matter of months, but some are already predicting it may drastically alter the IOL landscape and push current monofocal designs to the periphery.

Associate Professor Michael Lawless, from the Vision Eye Institute (VEI) and University of Sydney, has implanted 39 Vivity IOLs – the most of any Australian surgeon – in a range of patients for the past six months. He is now convinced of the hype that’s building around the presbyopia-correcting, non-diffractive device.

Michael Lawless.

“I am pretty confident now that this will replace monofocals and become my default lens,” he says.

“I guess this is the lens I’ve been looking for for 25 years. It would be nice if it guaranteed the ability to read without glasses completely – it doesn’t quite do that – but in every other respect it is such a leap forward compared to all other designs. And I think people are just only starting to realise this.”

Lawless, who is an Alcon and Zeiss consultant, says a key difference with the Vivity IOL is that it offers a visual disturbance profile comparable to a monofocal lens.

This, he says, sets it apart from other EDOF lenses, which typically provide “the double whammy” in terms of photic phenomena – such as glare, haloes and reduced contrast sensitivity – and some spectacle dependence for near activities.

While regular Vivity patients (some opt for mini-monovision) may still require light reading glasses, ophthalmologists believe this advancement in EDOF lens development could have an impact on both the monofocal and, to a lesser extent, multifocal markets.

“I’ve put it in a range of people, including those with macular disease, people have had Lasik in the past, people who drive at night and I’ve now been able to follow them enough to now say that it definitely performs like a monofocal lens in terms of photic phenomena and quality of vision – and they get about a dioptre and a half of extra near and intermediate vision,” he says.

“I don’t really see the use of a monofocal lens now, unless the patient requires something outside the power range available. With what I know after six months, I feel obligated to tell my patients about this lens.”

While Alcon will reveal the mechanism of action of its novel technology at an official Australian launch event soon, its product information states Vivity is a non-diffractive extended vision posterior chamber IOL.

Its depth of field extension and monofocal-like visual disturbance profile are achieved through wavefront focusing technology located on the IOL’s anterior surface. Like a monofocal, the technology utilises essentially all of the transmitted light energy across the range of vision. The location of the wavefront focusing optic is identical for all lens powers, with the anterior surface designed with negative spherical aberration to compensate for the positive spherical aberration of the cornea. It also provides protection against UV light and filters blue light.

According to a press release for the European launch in March, recent clinical trials found Vivity provides ‘very good’ quality of vision at distance and intermediate ranges in bright and dim light. Without glasses, 94% of patients reported ‘good’ or ‘very good’ vision at distance, and 92% reported ‘good’ or ‘very good’ vision at arm’s length.

Additionally, Vivity patients reported such low levels of starbursts, halos and glares that its visual disturbance profile was said to be comparable to a monofocal lens.

Like Lawless, Professor Gerard Sutton, also from VEI and University of Sydney, sees Vivity becoming a default option in future.

Gerard Sutton.

He has been using the lens since the beginning of the year and is yet to find any significant trade-offs. He is not an Alcon consultant.

“With the studies that are occurring, I suspect we’re going to see better binocularity and similar visual quality outcomes compared to a monofocal lens, and I suspect this is where we are heading in terms of the standard lens selection for surgeons in Australia, but it is important to do the studies so we have data to back up that initial impression.”

Sutton and Lawless agree that multifocals will continue to have a place for patients who desire complete spectacle independence. Monofocals may also be required when there are doubts over the patient’s optical system or if they fall outside the Vivity power range. But the Vivity will create a more nuanced conversation.

“If someone comes to me wanting the maximum chance of never having to wear glasses again, then I’ll talk about the multifocal or trifocal options, but you’ve got to be selective about who you offer it to – not just in terms of people’s careers, such as truck drivers who drive at night, but you need to consider the health of their ocular system,” Sutton explains.

“That involves no significant dry eye and no irregular corneas, so there are a lot of restrictions on the multifocal lens that are not as relevant for the Vivity EDOF lens.”

As such, he says Vivity is for people who are prepared to accept they may still occasionally wear reading glasses.

“But they are going to get good visual quality and good social vision. This means they can check their emails, their phone, go down the shops and see what they are buying. They’re getting good binocular vision without having to worry about issues with night driving,” Sutton says.

While it’s important to stress to patients they may not be completely spectacle free for near activities, Sutton and Lawless are having success with those opting for mini-monovision (blended vision).

“With a bit of blended vision we move the near point of their non-dominant eye a little closer and the idea being that will further reduce their dependency on glasses. It’s important you don’t promise these patients they will be independent of glasses, although a lot of them are,” Sutton explains.

Additionally, centration of the Vivity IOL is not as critical compared with multifocal designs.

“It’s a bit more forgiving in that sense,” Sutton explains. “Occasionally over time a lens can tilt and that tends to induce aberrations in some multifocal lenses, but again that’s not as relevant for the Vivity lens.”

The AcrySof IQ Vivity remains in the pre-launch phase in Australia. Image reproduced with permission of Alcon.

Lawless discussed centration issues with the lens designer at the European Society of Cataract & Refractive Surgeons Congress in Paris last year. He was told that it wouldn’t cause visual disturbances, but may slightly impact its reading effect.

From a surgical perspective, Sutton says the uptake of the lens could be rapid once it’s supported by the outcomes of ongoing studies.

The Vivity adopts Alcon’s AcrySof IQ IOL platform, which is similar to those that ophthalmologists adopt for standard monofocals, and has been used in more than 120 million eyes globally.

“The lens material is exactly the same and so is the injector, so it’s a lens that most Australian surgeons will be very familiar with. There’s really no learning curve in terms of the surgery,” Sutton says.

Figure 1 – Design of the AcrySof IQ Vivity IOL Model DFT015 (all dimensions in millimeters), as per the Alcon Product Information.

When it comes to how Vivity will disrupt the market dynamics, Lawless anticipates it will have an impact on both the multifocal and monofocal categories.

However, he believes it will take at least another 18 months before Australian ophthalmologists begin to appreciate its potential.

“This is where it gets really interesting because I think the Vivity will tend to cannibalise part of the trifocal market, but there will be smaller place for trifocals,” Lawless says.

“Of more interest is the monofocal market. Monofocals are the mainstay of all lens companies, they’re not too expensive and that’s what is put in every day, all around the world. But why would you put that lens in somebody and make them more dependent on reading and intermediate glasses when you have got a lens that does the same job plus a bit more?”

An Alcon Australia and New Zealand spokesperson confirmed to Insight the company is in a pre-launch phase, with some early access surgeons assessing the technology and providing feedback to Alcon.

“The launch timing is under review due to COVID-19,” the spokesperson said.

“We are excited about the launch of this novel technology and the anticipation from the ophthalmic community. We look forward to sharing more information closer to official the launch date.”

  • This article was independently initiated and developed by Insight. Alcon had no influence on the content.